Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible for the actions of those working under them.

Rebecca Wood, speaking at the FDLI Enforcement, Litigation, and Compliance Conference, said many questions have been raised over so-called “vicarious” criminal liability — where a person, who did not commit wrongdoing, could be found liable for the acts of others at the company.

In addition, the FDA’s lawyers and investigators are considering whether a breach of a duty to act or to correct violations must occur before criminal charges are brought.